<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-109-0014-008T2</udiDi>
    <basicUdiDi>B-109-0014-008T2</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-008</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:44:00.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-007SY</udiDi>
    <basicUdiDi>B-109-0014-007SY</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-007</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:56.164Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-006SW</udiDi>
    <basicUdiDi>B-109-0014-006SW</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-006</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:55.346Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-005SU</udiDi>
    <basicUdiDi>B-109-0014-005SU</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-005</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:54.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-004SS</udiDi>
    <basicUdiDi>B-109-0014-004SS</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-004</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:52.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-003SQ</udiDi>
    <basicUdiDi>B-109-0014-003SQ</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:48.940Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-002SN</udiDi>
    <basicUdiDi>B-109-0014-002SN</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-002</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:47.338Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-109-0014-001SL</udiDi>
    <basicUdiDi>B-109-0014-001SL</basicUdiDi>
    <tradeName>iCLAS™ Shaped Stylet Accesory</tradeName>
    <deviceName>iCLAS™ Shaped Stylet Accessory</deviceName>
    <manufacturerName>Adagio Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001129</manufacturerSrn>
    <authorisedRepresentativeName>Qualrep Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000537</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>109-0014-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:43:46.543Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878960017</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878960017</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>960001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:33.737Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924446</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924446</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902444</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:32.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924422</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924422</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902442</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:31.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924125</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924125</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902412</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:28.926Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924064</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924064</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902406</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:27.733Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924040</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924040</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902404</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:26.536Z</lastUpdated>
  </row>
  <row>
    <udiDi>06938878924026</udiDi>
    <basicUdiDi>69388789SEC000ZW</basicUdiDi>
    <tradeName>06938878924026</tradeName>
    <deviceName></deviceName>
    <manufacturerName>APT Medical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000010698</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>902402</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-24T22:13:25.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729992738</udiDi>
    <basicUdiDi>01915060000000000000212MH</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS4110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:13:45.331Z</lastUpdated>
  </row>
  <row>
    <udiDi>08714729992806</udiDi>
    <basicUdiDi>01915060000000000000212MH</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS6310</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T17:13:45.276Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506015718</udiDi>
    <basicUdiDi>01915060000000000000299NP</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-31T19:28:27.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00191506015701</udiDi>
    <basicUdiDi>01915060000000000000299NP</basicUdiDi>
    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020380</emdnCode>
    <emdnDescription>ABLATION OF ARRHYTHMOGENIC FOCUS DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-05-31T19:28:26.747Z</lastUpdated>
  </row>
</eudamedExport>